CompletedPhase 1ACTRN12619001062112

A study to evaluate the biosimilarity of SBS6002 to Neulasta when administered to healthy participants

A Phase 1, Bioequivalence Trial Evaluating the Pharmacokinetic and Pharmacodynamic Biosimilarity of SBS6002 Versus Neulasta® Following Subcutaneous Administration to Healthy Volunteers

Sponsor

INC Research Australia Pty Ltd

Enrollment

150 participants

Start Date

Oct 9, 2019

Study Type

Interventional

Conditions

Neutropenia

Summary

This research project is being conducted to evaluate the bioequivalence and biosimilarity of SBS6002 to Neulasta when administered to healthy participants by comparing PK, PD, safety and tolerability.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria8

Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types. Subjects must meet all of the following criteria to be included in the study:
Male, non-smoker or social smoker.
Healthy as defined by:
a) the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Inclusion pre-dosing is at the discretion of the Investigator.
b) the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
c) absence of febrile or infectious illness within 1 week prior to dosing.
Provide signed written informed consent prior to the initiation of any study-specific procedures.
Willing and able to comply with the requirements of the protocol and be available for the planned duration of the trial.

Exclusion Criteria20

Subjects to whom any of the following applies will be excluded from the study:
Any clinically significant abnormality at physical examination at screening or on Day -1 of Period 1
Any clinically significant abnormal hematology, biochemistry and other laboratory test results found at screening.
Positive test for hepatitis B, hepatitis C, or HIV at screening.
Positive urine drug screen at screening or on Day -1 of Period 1.
History of allergic reactions or hypersensitivity to pegfilgrastim, filgrastim, E. coli-derived proteins, PEGylated proteins, or to any excipients of the study drug.
Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Clinically significant ECG abnormalities or vital sign abnormalities at screening.
History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening or positive alcohol test at screening or on Day -1 of Period 1.
History of significant drug abuse within one year prior to screening or use of soft drugs within 3 months prior to the screening visit or hard drugs within 1 year prior to screening.
Participation in any other investigational clinical study in which administration of an investigational study drug occurred within 30 days or 5 half-lives of the product (whichever is the longest) prior to screening.
Use of medication, other than topical products without significant systemic absorption.
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
Any past exposure to recombinant human G-CSF products and/or a known history of prior treatment with blood-cell colony stimulating factors, interleukins or interferons.
History of sickle cell trait or sickle cell disease.
History of pulmonary infiltrate or pneumonia within 6 months before the screening visit.
Signs or symptoms of chronic obstructive pulmonary disease.
Splenomegaly at screening or prior to Day 1.
Hereditary fructose intolerance.
Tattoos covering the potential study drug injection site.

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Interventions

Participants will be randomized to one of two possible sequences: Sequence 1: Single dose of 6 mg of SBS6002 (0.6 mL of 10 mg/mL pegfilgrastim solution, based on protein content only) via subcutaneou

Participants will be randomized to one of two possible sequences: Sequence 1: Single dose of 6 mg of SBS6002 (0.6 mL of 10 mg/mL pegfilgrastim solution, based on protein content only) via subcutaneous injection administered on the abdomen, followed by a washout period (of at least 42 days since dose of SBS6002), and a single dose of 6 mg of comparator via subcutaneous injection administered on the abdomen. Sequence 2: Single dose of 6 mg of comparator via subcutaneous injection administered on the abdomen, followed by a washout period (of at least 42 days since dose of comparator), and a single dose of 6 mg of SBS6002 (0.6 mL of 10 mg/mL pegfilgrastim solution, based on protein content only) via subcutaneous injection administered on the abdomen.